Tegaserod

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Tegaserod
File:Tegaserod chemical structure.png
File:Tegaserod Zelnorm.gif
Clinical data
Pregnancy
category
  • AU: B3
  • US: B (No risk in non-human studies)
Routes of
administration		Oral
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability10%
Protein binding98%
MetabolismGastric and hepatic
Elimination half-life11 ± 5 hours
ExcretionFecal and renal
Identifiers
CAS Number
PubChem CID
DrugBank
E number{{#property:P628}}
ECHA InfoCard{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
FormulaC16H23N5O
Molar mass301.39 g/mol

Tegaserod is a 5-HT4 agonist manufactured by Novartis and used for the management of irritable bowel syndrome and constipation.[1] Its use was the only drug approved by the United States Food and Drug Administration to help relieve the abdominal discomfort, bloating and constipation associated with irritable bowel syndrome. Its use was also approved to treat chronic idiopathic constipation.[2] It is currently marketed by Novartis under the trade names Zelnorm and Zelmac in the United States and abroad, respectively.

The drug functioned as a motility stimulant, achieving its desired therapeutic effects through activation of the 5-HT4 receptors of the enteric nervous system in the gastrointestinal tract. It also stimulates gastrointestinal motility and the peristaltic reflex, and allegedly reduces abdominal pain.[3]

Withdrawal from market

On March 30 2007, the U.S. Food and Drug Administration requested that Novartis withdraw Zelnorm from shelves. The FDA alleges a relationship between prescriptions of the drug and increased risks of heart attack or stroke.[4] An analysis of data collected on over 18,000 patients demonstrated adverse cardiovascular events in 13 of 11,614 patients treated with Zelnorm (a rate of 0.11%) as compared with 1 of 7,031 patients treated with placebo (a rate of 0.01%). Novartis states all of the affected patients had preexisting cardiovascular disease or risk factors for such, and further states that no causal relationship between tegaserod use and cardiovascular events has been demonstrated.[5] On the same day as the FDA announcement, Novartis Pharmaceuticals Canada announced that it was suspending marketing and sales of the drug in Canada in response to a request from Health Canada.[6] Some manufacturers in India, such as Cipla, seem to still have generic Tegaserod available in their listings[7] and some online merchants may be selling it.

References

  1. ↑ "New Data for Zelnorm®". Unknown parameter |accessyear= ignored (|access-date= suggested) (help); Unknown parameter |accessmonthday= ignored (help)
  2. ↑ "FDA approves first treatment for women with irritable-bowel syndrome". Unknown parameter |accessyear= ignored (|access-date= suggested) (help); Unknown parameter |accessmonthday= ignored (help)
  3. ↑ Rossi, S. (2004). Australian Medicines Handbook. Adelaide: Health Communication Network. ISBN ISBN 0-9578521-4-2 Check |isbn= value: invalid character (help).
  4. ↑ "Constipation drug pulled at FDA request". Unknown parameter |accessyear= ignored (|access-date= suggested) (help); Unknown parameter |accessmonthday= ignored (help)
  5. ↑ "Zelnorm" (PDF). Novartis. Retrieved 2007-03-30.
  6. ↑ "Novartis suspends Canadian marketing and sales of Zelnorm® in response to request from [[Health Canada]]". Retrieved 2007-03-30. URL–wikilink conflict (help)
  7. ↑ http://www.cipla.com/ourproducts/productlist/t.htm

http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/2007/zelnorm_pc-cp_2_e.html

External links

Template:Pharma-stub Template:Drugs for functional gastrointestinal disorders Template:WikiDoc Sources

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